Evaluation of Proposed EZ2go Complete Bowel Cleansing System

Colonoscopy Clinical Trial

Official title:

Randomized, Single Blinded Study of Proposed EZ2go Complete Bowel Cleansing System: Evaluation of Its Safety, Efficacy and Patient Tolerance Compared to LOSO Prep, an Over the Counter Laxative Kit for Colonoscopy Bowel Preparation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838408
• Other study ID #: Pro00008184
• Status: Completed
• Phase: N/A
• First received: April 16, 2013
• Last updated: January 26, 2015
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Borland-Groover Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study aims to provide safety and efficacy data comparable to available over-the-counter bowel preparations prior to colonoscopy. While there are many bowel preparations available, most of them remain expensive and require prescription from a health provider. The investigators believe EZ2go Complete will provide a non-inferior colon cleansing in a more accessible way (over-the-counter).

To accomplish this goal, the investigators decided to evaluate the proposed EZ2go combination versus currently available over-the-counter bowel preparations. The investigators believe the EZ2go kit will not be inferior to current FDA approved over-the-counter bowel preparations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients referred for routine colorectal cancer screening or surveillance colonoscopy examinations.

• Male and Female participants 18 years of age and older.

• Female participants who are not pregnant or planning to become pregnant within the next 90 days, or are sterile or of non-childbearing potential.

• Negative urine test at the screening visit.

• Subject is able to read and understand the informed consent form and signs the informed consent form.

Exclusion Criteria:

• Contraindication to any of the bowel preparations being used in the study.

• Unable/unwilling to fill out patient questionnaires following procedure.

• Pregnant or lactating.

• Unwilling to perform indicated lab work.

• Lab results that would indicate stage 4-5 chronic kidney disease (GFR <30MI/min1.73 m2).

• Personal history of colorectal cancer.

• Personal history of colorectal or small bowel surgery.

• Participants have any condition that, in the investigators opinion, could interfere with the participation and completion of this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Colonoscopy
• Screening Colonoscopy
• Surveillance Colonoscopy

Intervention

Other:
• Ez2go Complete
EZ2Go Complete
• LoSo Prep
LoSo Prep ™ Magnesium Citrate plus Bisacodyl Kit Study Arm

Locations

Country	Name	City	State
United States	Borland-Groover Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Borland-Groover Clinic	Valley Medical Products, LLC is paying for the study and is the sponsor. The form would not go through with this listed.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Efficacy	The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale.	24 hours	No
Secondary	Evaluate the safety	A basic metabolic panel will be drawn at baseline and after the bowel preparation is complete to evaluate for any electrolyte and renal disturbances.	2 weeks	Yes

External Links

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